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PubMed2000

A comparison of elderly patients with aggressive histology lymphoma who were entered or not entered on to a randomized phase II trial.

The purpose of this study was to compare the baseline patient characteristics, treatments and outcomes of elderly patients with aggressive histology lymphoma who were entered or not entered onto a randomized phase II trial. We previously conducted a randomized phase II trial in patients > or = 65 years of age who had advanced stage intermediate grade lymphoma. A registry of all patients meeting the inclusion criteria for that trial was maintained. Many patients were not entered on to the randomized trial because of the presence of at least one exclusion criterion, or because of patient or physician choice. We have compared the baseline characteristics, treatment, and survival of the randomized and non-randomized patients. Results show that 68 consecutive patients met inclusion criteria for the randomized trial. Thirty-eight patients satisfied all eligibility criteria, consented, and were randomized; 30 patients (44%) were not entered. In comparison with randomized patients, non-randomized patients were older (mean 75.9 vs. 72.4 years; P=0.013), had a poorer performance status (P=0.0006), were less likely to be given treatment with curative intent (60% vs. 100%; P<0.001), and were less likely to complete 6 cycles of such treatment (27% vs. 89%; P<0.001). With a median follow-up of > 7 years, actuarial 5-year survival is superior in randomized patients (44.3% vs. 10%; P<0.00001). In conclusion, a substantial number of patients did not enter our randomized trial phase II trial and had different characteristics, received different therapy and had inferior outcomes in comparison with randomized patients. Randomized trials of therapy for elderly lymphoma patients may include special selection criteria and results may not be generalizable to a substantial proportion of other older patients.

Actuarial Analysis↗

PubMed2001

Enteral versus parenteral nutrition for acute pancreatitis.

BACKGROUND: Acute pancreatitis creates a catabolic stress state promoting a systemic inflammatory response and nutritional deterioration. Adequate supply of nutrients plays an important role to ensure optimum recovery. Total parenteral nutrition (TPN) has been the standard practice for providing exogenous nutrients to patients with severe acute pancreatitis. However, recent data suggest that enteral nutrition (EN) is feasible. Thus, a comparison of EN and TPN in patients with acute pancreatitis needs to be made. OBJECTIVES: To compare the effect of total parenteral nutrition (TPN) versus enteral nutrition (EN) on mortality, morbidity and length of hospital stay in patient with acute pancreatitis. SEARCH STRATEGY: Trials were identified by computerized searches of The Cochrane Controlled Trials Register, MEDLINE, and EMBASE. Additional studies were identified and included where relevant by searching Scisearch, the bibliographies of review articles and identified trials, and personal files. The search was undertaken in August, 2000. No language restrictions were applied. SELECTION CRITERIA: Randomized clinical trials, in which nutrition support with TPN were compared to EN in patients with acute pancreatitis. DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted data and assessed trial quality. Information was collected on death, length of hospital stay, systemic infection, local septic complications, and other local complications. MAIN RESULTS: Two trials with a total of 70 participants were included. The relative risk (RR) for death with EN vs TPN was 0.56 (95% CI 0.05 to 5.62). Mean length of hospital stay was reduced with EN (WMD -2.20, 95% CI -3.62 to -0.78). RR for systemic infection with EN vs TPN was 0.61 (95% CI 0.29 to 1.28). In one trial, RR for local septic complications and other local complications with EN vs TPN was 0.56 (95% CI 0.12 to 2.68) and 0.16 (95% CI 0.01 to 2.86) respectively. REVIEWER'S CONCLUSIONS: Although there is a trend towards reductions in the adverse outcomes of acute pancreatitis after administration of EN, clearly there are insufficient data to draw firm conclusions about the effectiveness and safety of EN versus TPN. Further trials are required with sufficient size to account for clinical heterogeneity and to measure all relevant outcomes.

Acute Disease↗

PubMed2006

Enteral tube hub as a reservoir for transmissible enteric bacteria.

Enteral feeding is a risk factor for cross transmission of microbes. Administration set tubing can be colonized by organisms present in the enteral tube hub; molecular typing has demonstrated genetic relatedness of enteric bacteria isolated from both sites. Strict attention to infection control measures is imperative when handling enteral feed apparatuses.

Bacteria↗

PubMed1987

Enteral and parenteral nutrition in patients with enteric fistulas and short bowel syndrome.

Significant advances in the use of enteral and parenteral nutrition in patients with either enteric fistulas or short bowel syndrome include increased usage of enteral nutrition because of its trophic effects on the gut and increased usage of both enteral and parenteral nutrition in the home setting. Current investigations are directed toward identifying gut-specific fuels and dietary and pharmacologic enhancement of nutrient utilization.

Adaptation, Physiological↗

PubMed1996

Clinical outcome and immunology of postoperative arginine, omega-3 fatty acids, and nucleotide-enriched enteral feeding: a randomized prospective comparison with standard enteral and low calorie/low fat i.v. solutions.

In a prospective randomized trial in patients undergoing major abdominal surgery, the impact of a new enteral formula supplemented with arginine, omega-3 fatty acids, and nucleotides (A, n = 14) on immunological parameters was compared with a standard enteral formula (B, n = 14) and a low calorie/low fat intravenous solution (C, n = 13). Four days postoperatively, a statistically significant decrease in total leukocyte count (A, 9.0 +/- 2.9; B, 8.0 +/- 2.4; C, 11.1 +/- 3.5 x 10(6) cells/mL; A versus C, B versus C; p < 0.05), higher percentage of lymphocytes (A, 14.3 +/- 4.9; C, 8.2 +/- 6.1; p < 0.05), and decreased median CRP levels (A, 80.4 [69.9]; B, 70 [74]; C, 88.5 [142] in mg/L; A versus C, p < 0.05; B versus C; p < 0.05) were observed in the enteral nutrition groups. The expression of activated surface antigen HLA-DR was diminished on CD14+ cells over 4 d (A, 58.2 [39.2]; B, 52.2 [36.2]; C, 76.6 [25.2] in %; A versus C, p < 0.05; B versus C, p < 0.05) and 8-10 d (A, 37.9 [31.4]; C, 58.5 [37.6]; p < 0.05) postoperatively. Significantly enhanced median phagocytic activity of CD14+ monocytes and granulocytes was observed in group C 8-10 days postoperatively (A, 83.3 [11.8]; B, 71.6 [34.1]; C, 87.4 [10.8]; A versus B, B versus C, p < 0.05; and A, 75.7 [10.0]; B, 69.0 [37.8]; C, 80.0 [10.1] in %, B versus C, p < 0.05, respectively). Postoperative hospital and intensive care unit stay was similar among the three groups; however, infectious complications were less frequent in group A (A versus C, p = 0.15). Thus, a modified enteral nutritional support and supplementation may influence the immune competence toward a more efficient defense response.

Aged↗

PubMed2007

Blends of reverse enteric polymer with Enteric and pH-independent polymers: mechanistic investigations for tailoring drug release.

Blends of conventional reverse enteric polymer with enteric polymers result in insoluble polyelectrolyte complexes and hence cannot be used in film coatings. We report a new set of miscible blends of a new reverse enteric polymer (NREP) synthesized by us with enteric and pH-independent polymers. The nature of interactions between polymers in the blends has been established by analyzing Fourier transform infrared (FTIR) spectra. The extent of interaction has been investigated by thermal analysis and quantified in terms of parameters K1 and K2 in the Schneider equation. Based on these values, the interactions between NREP and these polymers have been ranked in the order EC (ethylcellulose) < ES (Eudragit S) < HPMCP (hydroxypropyl methylcellulose phthalate). The quantification of interactions in blends helps explain the release pattern of cefuroxime axetil (CA) at gastric pH and tailor the release of other drugs according to their pharmacokinetic characteristics. The understanding also provides a more rational approach for selection of polymers and their content in the coating compositions, rather than an empirical approach.

Cellulose↗

PubMed1989

[Comparison of clinical efficacy of lomefloxacin (LFLX, NY-198) and pipemidic acid (PPA) in the treatment of infectious enteritis by a double-blind method. The Japan Research Committee of Lomefloxacin Research Group Enteritis].

The clinical efficacy, safety and usefulness of lomefloxacin (LFLX, NY-198), a new quinolone antimicrobial agent, were compared with those of pipemidic acid (PPA) in the treatment of infectious enteritis (bacillary dysentery, enteropathogenic Escherichia coli enteritis and Campylobacter enteritis) by a double blind method. Daily dosage of LFLX and PPA was 600 mg and 2000 mg, respectively administered orally divided into 4 doses. The duration of the treatment was 5 days. Of 290 cases studied, 100 cases were excluded and 21 cases were dropped from analysis of effectiveness and usefulness. The effectiveness and usefulness was evaluated in 169 cases (LFLX group: 83, PPA group: 86). There was no significance difference between the two groups in any background characteristics. The results obtained were as follows: 1. In 73 symptomatic patients (LFLX group: 35, PPA group: 38) on the day of the beginning of administration, the clinical effect was 91.4% in the LFLX group and 84.2% in the PPA group with no significant difference between the two groups. 2. In a total of 184 strains (LFLX group: 90, PPA group: 94), the bacteriological effects of LFLX (93.3%) was superior to that of PPA (80.9%) with significant difference (p = 0.0153). 3. In 169 evaluable patients, the global clinical effects of LFLX (92.8%) was superior to that of PPA (79.1%) with a significant difference (P = 0.0144). 4. Side effects were observed in 1 (0.7%) of the 141 patients in the LFLX group and none of the 143 patients in the PPA group. Abnormal laboratory test values were noted in 10 (7.6%) of the 132 patients treated with FLLX and 7 (5.1%) of the 136 patients treated with PPA, but they as no significant difference between the two groups. 5. In 169 evaluable patients, the clinical usefulness of LFLX (91.6%) was superior to that of PPA (76.7%) with a significant difference (P = 0.0111). From these results, LFLX is considered to be a clinically useful medicine in the treatment of infectious enteritis including bacillary dysentery.

4-Quinolones↗

PubMed1989

[Clinical trial of T-3262 (Tosufloxacin tosilate) on Salmonella enteritis, and fecal drug concentration and change in the fecal microflora in the acute diarrheal patients. Japan Research Committee of T-3262, Research Group for Acute Infectious Enteritis].

For the purpose of evaluation of clinical efficacy, safety and usefulness on Salmonella enteritis, T-3262 (Tosufloxacin tosilate), a newly developed pyridone-carboxylic acid derivative, was administered to a total of 103 patients and carriers. In addition, in vitro antibacterial activity of T-3262 was determined against the clinical isolates, and compared with those of nalidixic acid (NA), pipemidic acid (PPA), enoxacin (ENX), norfloxacin (NFLX) and ofloxacin (OFLX). And when T-3262 was administered to the patients of acute infectious enteritis, fecal drug concentration and their correlation to the changes in the fecal microflora were investigated. The daily dose of 450 mg T-3262 was administered orally three times after meal for 7 days. A total of 63 cases were evaluated (one case of mixed infection caused by Shigella flexneri and Salmonella sp. was included). The clinical efficacy was good in all the enteritis (N = 6). As the bacteriological effect, 60 out of 61 were eradicated, and eradication rate was 98.4%. Adverse effects were observed in four of 102 cases (3.9%), consisting of one with skin rash, one with nausea, headache and stomatitis and two with soft stools. Deteriorations in laboratory findings were seen in 5 of 23 cases (17.4%), consisting of one with elevated GOT, two with elevated GOT and GPT, one with elevated BUN and one with increased eosinophiles count, although they were all slight in degree. MICs of T-3262 which inhibited 90% of the isolates of Salmonella spp. was 0.05 microgram/ml, which was the lowest among the quinolone derivatives tested. The values of the fecal drug concentration of 7 cases of acute infectious enteritis, to which T-3262 administered, were higher than that of MIC90 and recovery rates of T-3262 were distributed from 2.85 to 46.3%. The degrees of changes of the drug concentrations were dependent on individual cases, and did not show the same trend. In addition, changes in the fecal microflora with in 24 hrs after T-3262 administration did not show the same trend.

4-Quinolones↗

PubMedDate not supplied

Effect of enteral feeding bag composition and freezing and thawing upon vitamin stability in an enteral feeding solution.

The effect of enteral feeding bag composition and freezing and thawing upon the stability of riboflavin and vitamins A and E in an enteral feeding solution was tested. Feeding bags composed of either polyvinyl chloride or polyethylene were filled with an enteral feeding solution. The samples were frozen for 3 months, thawed in warm water, and allowed to stand in room temperature for 12 hr. Samples for vitamin analysis were obtained prior to freezing, upon thawing, and at 12 hr after thawing. No significant differences in vitamin stability due to bag composition or time were seen. These results support the viability of the concept of mixing large batches of enteral feeding solution, and freezing aliquots in individual feeding bags for later use.

Drug Stability↗

PubMed1991

The efficacy and tolerability of enteric and non-enteric coated naproxen tablets: a double-blind study in patients with osteoarthritis.

A double-blind, crossover study was undertaken to compare the efficacy and tolerability of a novel enteric coated 500 mg naproxen tablet with normal release 500 mg naproxen in patients with osteoarthritis. Eighty-eight patients were randomly allocated to receive enteric coated naproxen as a single daily dose of 2 tablets at night or 1 normal release naproxen tablet twice daily for a period of 3 weeks, followed by the alternative treatment for a further period of 3 weeks. The results of patient and doctor assessments showed that both treatments were increasingly efficacious, with a significant period effect found in the measures for pain on passive movement and duration of morning stiffness. No significant treatment differences were seen in any of the measures of efficacy and tolerability, although there were more withdrawals on normal release than on enteric coated naproxen (p = 0.07). It was concluded that enteric coated naproxen given as a single 1 g dose at night and normal release 500 mg naproxen given twice daily are equally efficacious and well tolerated.

Adult↗

PubMed1978

[Necrotizing enteritis in suckling pigs (Clostridium perfringens type C enterotoxemia). II. Toxin formation, heat and drug resistance of Clostridium perfringens strains isolated from suckling pigs and broilers with necrotizing enteritis].

Nineteen Clostridium perfringens Type C strains and ten foreign control strains of subtypes C1, C3, and C4 were tested for their toxin formation and spore resistance to heat. The 19 Type C strains had been isolated from unweaned piglets in the context of necrotising enteritis outbreaks in the GDR. The Clostridium perfringens Type C strains formed beta-toxin, but they failed to form epsilon-toxin or gamma-toxin, alpha-toxin was successfully recorded from 15 of the 19 strains tested from unweaned piglets. The minor-lethal toxin fractions were also tested, with delta-toxin being recorded from all strains, non-alpha-delta-theta-toxin from six, theta-toxin from five, and K-toxin from one. Tests for delta-toxin, lambda-toxin, and mu-toxin were negative. The Clostridium perfringens Type C strains isolated in the GDR from unweaned piglets with necrotising enteritis were, basically, identical with those described in Denmark by von Hogh (1967) with regard to toxin formation. Clostridium perfringens strains cultured in broilers with necrotising enteritis were characterised by regular toxin production in the context of alpha, theta, delta as well as non-alpha-delta-theta. They failed to form beta, epsilon, gamma and lambda, while mu-toxin was formed by them quite irregularly. They, consequently, are Type A strains. Resistance to chloramphenicol and/or oxytetracycline was exhibited by 78.5 per cent of 237 tested Clostridium perfringens strains which had been isolated from unweaned piglets and broilers with necrotosing enteritis. Multiple resistance was recorded from 33.9 per cent. All strains were susceptible to penicillin, nitrofurantoin, and erythromycin.

Animals↗

PubMed2002

An increase in overdose mortality during the first 2 weeks after entering or re-entering methadone treatment in Amsterdam.

AIMS: It has been suggested that starting and temporarily discontinuing methadone treatment is related to an increased risk in overdose mortality. This study describes the incidence of overdose mortality in relation to time after (re)entering or leaving treatment. DESIGN: A dynamic cohort of 5200 Amsterdam methadone clients was observed during treatment and (a maximum of 1 year) after treatment. FINDINGS: Between 1986 and 1998, 29,729 person-years (py) and 68 overdose deaths were recorded, leading to an overdose mortality rate of 2.3/1000 py (2.2 during and 2.4 after treatment). A modest increase was observed during the first 2 weeks after (re)entering treatment; 6.0/1000 py (rate ratio: 2.9; 95% confidence interval 1.4; 5.8). Directly after leaving treatment no increase was observed. CONCLUSIONS: Inhaling heroin, common among Amsterdam heroin users, is thought to account for low OD mortality rates both during and after treatment. Accumulation of methadone, inadequate assessment of tolerance of known clients re-entering treatment and concurrent periods of stress or extreme heroin use when entering treatment are mentioned as possible explanations of the increased risk within the first 2 weeks. An Australian study reported a much higher increase. The modest increase in Amsterdam is explained by low background risk of overdose mortality, low starting dosage and the low threshold to treatment.

Adult↗

PubMed2002

Detection of enteric adenoviruses in children with acute gastro-enteritis in Blantyre, Malawi.

In a 2-year hospital-based study of acute gastro-enteritis in children under 5 years of age in Blantyre, Malawi, enteric adenoviruses were detected by enzyme immunoassay in 11 (1.4%) of 786 inpatients and in 12 (3%) of 400 outpatients. Enteric adenoviruses were also detected in four (0.8%) children without diarrhoea admitted to hospital. Enteric adenoviruses account for only a minority of cases of diarrhoea in children hospitalised in Malawi.

Acute Disease↗

PubMed1993

Studies of the enteric nervous system in Alzheimer disease and other dementias of the elderly: enteric neurons in Alzheimer disease.

Studies of the myenteric (Auerbach) plexus of esophagus, stomach, small intestine, colon, and rectum, by microdissection and pointcount morphometry, for 18 patients with Alzheimer disease (AD), eight with other types of dementia of the elderly, non-demented elderly patients, and younger control patients, show a normal loss of enteric neurons and plexus mass with age, comparable to that reported by others for rats and guinea pigs. Values for patients with AD or other non-AD dementias did not differ from those for elderly controls. Enteric neurons in AD or the other dementias studied showed no definite stain with ALZ-50, a monoclonal antibody to a derivative of the microtubule-associated protein tau, which stains degenerating cerebral neurons in AD. Although the processes in the central nervous system in AD affect some neurons derived from the neural plate, the results of this study suggest that the enteric neurons, which are of neural crest origin, are not affected in AD. Enteric neurons, at least by the methods of this study, do not provide a useful peripheral marker for AD.

Age Factors↗

PubMed2003

A new method for the experimental production of necrotic enteritis and its use for studies on the relationships between necrotic enteritis, coccidiosis and anticoccidial vaccination of chickens.

A new method for the experimental production of necrotic enteritis in chickens is described. The main features are the use of a diet high in wheat and fish meal content; oral administration of a non-lethal inoculum of the coccidium Eimeria maxima followed 6 days later by the bacterium Clostridium perfringens type A per cloaca, so that the bacterial inoculum is deposited at the time and place when and where the intestinal coccidial lesions are maximal; grading of coccidial and clostridial lesions in individual birds sampled during the 14 days following the coccidial infection. The new method was used to examine the relationship between clostridial and coccidial infections. Frank coccidiosis, caused by virulent E. maxima, exacerbated the lesions of necrotic enteritis and other clinical effects due to a subsequent challenge with virulent C. perfringens type A. Immunization with a live, pentavalent, attenuated anticoccidial vaccine (Paracox-5) protected against a severe challenge with heterologous E. maxima. Furthermore, vaccination with Paracox-5, by virtue of its protection against clinical coccidiosis due to the E. maxima challenge, indirectly protected birds against a subsequent challenge with virulent C. perfringens. The results are reconciled with previous field observations on concomitant coccidiosis and necrotic enteritis in chicken flocks.

Animals↗

PubMed2003

CMV enteritis causing ileal perforation in underlying lupus enteritis.

We report a case of cytomegalovirus (CMV) enteritis in a 31 year-old -woman with lupus enteritis. In August 2002 the patient complained of severe abdominal pain. An abdominopelvic CT scan at the time showed free air in the peritoneal cavity and wall thickening of the ileal loop. She was diagnosed as having panperitonitis due to an ileal perforation, and underwent an emergency laparotomy. The surgical specimen revealed CMV inclusion bodies in the infarcted lesion. Her symptoms improved following the initiation of ganciclovir therapy. To the best of our knowledge, this is the first report in the English literature of an ileal perforation due to CMV infection in a patient with lupus enteritis.

Adult↗

PubMed2003

Comparison of a high-protein disease-specific enteral formula with a high-protein enteral formula in hyperglycemic critically ill patients.

AIMS: To determine whether a specific high-protein enteral formula with a similar caloric percentage of fat and carbohydrates achieves greater control over glycemic levels and reduces insulin requirements in hyperglycemic critically ill patients when compared to a control high-protein enteral formula. DESIGN: A prospective, randomized, controlled, single-blind trial in two University Hospital Intensive Care Units in Spain. METHODS: We enrolled 50 patients with diabetes mellitus or stress hyperglycemia with basal glycemia > or =160 mg/dl and indication for enteral nutrition > or =5 days. Patients with severe kidney failure, liver failure or obesity were excluded from the study. In the first 48 h of admission, after randomization, 26 patients received the study diet and 24 patients received the control diet. The variables were monitored for 14 days. The Harris-Benedict formula with a fixed stress factor of 1.2 was used to calculate caloric needs. Insulin was administered by continuous infusion. An intention-to-treat analysis was performed. RESULTS: On admission, there were no differences between the study and control group in plasma glucose levels (mg/dl) (190.9+/-45 vs 210.3+/-63) and capillary glucose levels (mg/dl) (226.1+/-73 vs 213.8+/-67). After the feeding trial, there were differences between the study and control group in plasma glucose levels (mg/dl) (176.8+/-44 vs 222.8+/-47, P=0.001), capillary glucose levels (mg/dl) (163.1+/-45 vs 216.4+/-56, P=0.001), insulin requirements/day (IU) 8.73 (2.3-27.5) vs 30.2 (21.5-57.1) (P=0.001), insulin/received carbohydrates (UI/g) 0.07 (0.02-0.22) vs 0.18 (0.11-0.35) (P=0.02) and insulin/received carbohydrates/kg 0.98 (0.26-3.59) vs 2.13 (1.44-4.58) (P=0.04). These differences remain in a day-to-day comparison. There were no differences in the analytical tests, or in digestive or infectious complications. Intensive Care Unit length of stay, mechanical ventilation and mortality were similar in both groups. CONCLUSIONS: Hyperglycemic critically ill patients fed with a high-protein diet with a similar caloric percentage of fat and carbohydrates show a significant reduction in plasma glucose levels, capillary glucose levels and insulin requirements in comparison to patients on a conventional high-protein diet. This better glycemic control do not modify Intensive Care Unit length of stay, infectious complications, mechanical ventilation and mortality.

APACHE↗

PubMed2002

Enteral nutrition and enteral tube feeding. Review of the evidence.

Improvements in delivery systems for enteral feeding, in formulas, and in the understanding of complications have made the technology for enteral feeding easy to apply. Adequate nutrients can be delivered, and individual tolerance for feeding is acceptable. The remaining question is when to apply the technology. Formula selection should be as simple as possible. Aspiration and other early complications are a serious risk and are not diminished by route of feeding. Long-term enteral feeding is associated with a high complication rate, with high mortality, and may not be effective.

Aged↗